FDA plans program to increase availability of generic drugs

WASHINGTON The Food and Drug Administration has outlined a program that in theory will increase the number of generic drugs available to consumers and healthcare providers. The program will be titled GIVE, the Generic Initiative for Value and Efficiency.

As part of GIVE, the FDA will revise the review order for certain drug applications. For example, first generic products, for which there are no blocking patents or exclusivity protections on the reference-listed drug, are identified at the time of submission for expedited review. This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster.

The president of the Generic Pharmaceutical Association, Kathleen Jaeger, was not impressed with the announcement made by the FDA. “While we all share the goal of increasing efficiency in the generic approval system, another initiative, in name only, simply will not get the job done. What consumers need is for the FDA to address the core fundamental issues that are blocking timely consumer access to affordable generics. These core issues have been around for more than a decade and include the citizen petition process, scientific consults, enhanced communication, more inspection resources, accountability and structure of the Office of Generic Drug Program.

For years, the Agency has tinkered around the edges with programs and initiatives designed to increase efficiency but have proven to yield little in the way of significant results. There are serious legislative and regulatory issues that must be addressed to yield a true increase in the number of affordable generics brought to market. The generic industry stands ready to work with the Agency in tackling these issues to increase consumer access. That’s why we have entered into good faith efforts with the FDA to create a meaningful user fee program that truly results in timely generic access.”

The FDA did approve over 30 percent more generic products in fiscal 2007 over last year, for a total of 682, which is a record for the agency.

FDA increases potency of levothyroxine products

WASHINGTON The Food and Drug Administration is strengthening the potency specifications for levothyroxine sodium to ensure the drug retains its potency over its entire shelf life.

The agency is increasing the specifications from a 90 to 110 percent potency range to a 95 to 105 percent range. The percent ranges were changed following concerns about the product by healthcare professionals and patients.

Data taken by the FDA showed that some of the levothyroxine products like blister packs degrade quicker than other package types. Also, some of the strengths have been shown to degrade more rapidly than others.

Manufacturers and marketers have two years to comply with the revised specification. Levothyroxine sodium products are used by over 13 million patients.

FDA to review heart problems from osteoporosis drugs

WASHINGTON The Food and Drug Administration is looking at new safety data on reports of atrial fibrillation in patients taking bisphosphonates.

Bisphosphonates are used to treat osteoporosis. The FDA is looking into the issue after a study in the May 3rd issue of the New England Journal of Medicine reported increased rates of serious atrial fibrillation in patients taking Fosamax and Reclast.

The FDA has performed an initial review and found that there was not a large enough group of people who were at risk for atrial fibrillation and would not as of right now ask for healthcare professionals to change their prescribing habits or to tell patients to change their use of the drugs.

The agency is seeking additional data to perform an in-depth review of the issue that could take up to one year to conclude.

RELATED NEWS

The Food and Drug Administration has approved a generic of Hoffman-La Roche’s Tamiflu (oseltamivir phosphate) capsules from Lupin. The company’s generic will be available in 30-, 45- and 75-mg dosage strengths.
The product is inficated to treat acute, uncomplicated influenza A and B in patients 2 weeks of age and older, as well as to prevent influenza A and B in patients 1 year old and older. The drug had U.S. sales of roughly $467.8 million for the 12 months ended October 2017, according to IQVIA data.

Behavioral health pharmacy and telepsychiatry company Genoa, a QoL Healthcare Company, has reached a big number with its remote psychiatry offering. The Tukwila, Wash.-based company announced Tuesday that it had facilitated more than 100,000 telepsych consultations on its video conferencing platform.
Genoa attributes the milestone to its recent buildup of its telepsychiatry operations, which grew to include 35 in 2017 from 20 at the start of the year, and included 250 providers. In 2017, the company grew to serve more than 2,500 patients per week.

This year's flu continues to be Texas big, according to the Walgreens Flu Index released Wednesday, as the top 10 communities experiencing the greatest amount of flu incidence were all located in the Lone Star State for the week ended Jan. 6.
Iowa, Idaho and Arkansas rank behind Texas in terms of flu activity. And Montana, Idaho and Iowa ranked highest among states experiencing flu activity gains.

Amneal Biosciences has launched its generic of Otsuka’s Busulfex (busulfan injection, 6 mg/ml). The product is indicated to treat chronic myelogenous leukemia.
Amneal said that its generic is available in cartons of eight single-dose vials, each of which contains 60 mg of the drug in a 10-ml clear sterile solution. The product is made without natural rubber, latex, gluten or preservatives, Amneal said.
The drug had U.S. sales of roughly $80 million for the 12 months ended October 2017, according to data from IQVIA.

Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela.
Amneal also launched five other products in addition to sevelamer carbonate:

Forgotten Password

Registration complete

REGISTER

USERNAME *

Spaces are allowed; punctuation is not allowed except for periods, hyphens, and underscores.

E-MAIL ADDRESS *

A valid e-mail address. All e-mails from the system will be sent to this address. The e-mail address is not made public and will only be used if you wish to receive a new password or wish to receive certain news or notifications by e-mail.

Password *

Confirm Password *

Please choose a password for your account; it must be 8 - 30 characters. .

First Name *

Last Name *

Company Name *

Job Title *

ZIP *

Are you a *

Retailer or Healthcare professional

Non-Retailer

How many stores do you operate?: *

Which best describes the business/industry you work in?: *

Which best describes your job title?: *

Please select the newsletters you would like to subscribe to

DSN A.M.
Daily news stories covering the retail drug industry

Breaking News
First-to-the-market with developing stories in the industry